Contrafacção/falsificação de medicamentos
Miniatura indisponível
Data
2012
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A panóplia de medicamentos e produtos de saúde existentes no mercado é enorme, existindo uma escolha alargada para os consumidores. Contudo, por vezes os preços são elevados; o medicamento que o consumidor quer não é legal no país onde se encontra; o consumidor, por vergonha, não se desloca a locais licenciados para comprar o medicamento que quer ou, o país ainda não tem acesso a um determinado medicamento inovador. E por estas razões o consumidor pode obter medicamentos falsificados através da cadeia ilegal de abastecimento, sendo a internet uma via provável de acesso. Contudo não é apenas na cadeia ilegal de abastecimento que se corre o risco de obter produtos falsificados. A cadeia de abastecimento legal tornou-se complexa e o controlo e fiscalização da mesma começou a ser mais difícil de realizar. Esta complexidade e o facto do sistema regulamentar não estar ainda bem implementado, levou ao aparecimento de produtos falsificados na cadeia legal. Para o controlo regulamentar deste problema, ao fim de alguns anos de debate e modificações à proposta existente, foi lançada na União Europeia a Directiva 2011/62/EU que pretende impedir a introdução de medicamentos falsificados na cadeia de abastecimento legal. A nível europeu existem iniciativas e organizações, tais como a International Medical Products Anti-Counterfeiting Taskforce(IMPACT), a Medicrime, Working Group of Enforcement Officers(WGEO), Pharmaceutical Security Institute(PSI), entre outras,cujo objectivo principal é o combate à contrafacção. São organizações e iniciativas com um grau de importância elevado devido ao trabalho que realizam. Para além destas acções as entidades reguladoras dos vários países europeus têm os Single Points of Contact (SPOCs) que permitem a troca de informação e colaboração internacional para que todos tenham acesso à mesma informação e a casos detectados. Em Portugal, o INFARMED I.P. é a Autoridade Nacional do Medicamento e Produtos de saúde e desta autoridade depende a fiscalização e controlo dos diversos intervenientes no ciclo do medicamento. Existe no INFARMED I.P. um departamento designado de Célula 3C que trabalha diariamente para o combate à contrafacção de medicamentos a nível nacional.
São pontos essenciais no combate à contrafacção de medicamentos, que a Directiva seja implementada a nível nacional e que os esforços e cooperação entre os vários países perdurem para que haja uma diminuição do risco nos próximos anos.
The variety of drugs and health products on the market is huge and there is a wide choice for consumers. However, sometimes the prices are high, the product that the consumer wants is not legal in his country, the consumer, for shame, doesn´t buy at licensed places, or the country doesn’t have access to a particular innovative drug. And for these reasons the consumer can get counterfeit drugs through illegal supply chain, and the Internet is a likely route of access. However, it isn’t just in the illegal supply chain that the consumer can get counterfeiting products. The legal supply chain has become complex and the supervision difficult to accomplish. This complexity and the fact that the regulatory system isn’t well implemented yet, has led to the appearance of counterfeit goods in the legal chain. For the regulatory control of this problem, after several years of debate and amendments to the first proposal, was launched in the EU the 2011/62/EU Directive which aims to prevent the introduction of counterfeit medicines in the legal supply chain. In Europe exists many initiatives and organizations such as the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), Medicrime, Working Group of Enforcement Officers (WGEO), Pharmaceutical Security Institute (PSI), among others, whose main objective is to combat counterfeiting. They are organizations and initiatives with a high level of importance due to their work. Beyond these actions, Drug Regulatory Authority (DRA) have the Single Points of Contact (SPOCs) that enable information exchange and international collaboration so that everyone has access to the same information and cases detected. In Portugal, INFARMED I.P is the National Authority of Medicines and Health Products, and this authority has a duty to supervision and controls the stakeholders in the product cycle. In Infarmed, a department called 3C Cell is working daily to combat counterfeit medicines nationally. Some points are essential in combating counterfeiting medicines such as the implementation of the new Directive nationally and the continuation of cooperation between countries.
The variety of drugs and health products on the market is huge and there is a wide choice for consumers. However, sometimes the prices are high, the product that the consumer wants is not legal in his country, the consumer, for shame, doesn´t buy at licensed places, or the country doesn’t have access to a particular innovative drug. And for these reasons the consumer can get counterfeit drugs through illegal supply chain, and the Internet is a likely route of access. However, it isn’t just in the illegal supply chain that the consumer can get counterfeiting products. The legal supply chain has become complex and the supervision difficult to accomplish. This complexity and the fact that the regulatory system isn’t well implemented yet, has led to the appearance of counterfeit goods in the legal chain. For the regulatory control of this problem, after several years of debate and amendments to the first proposal, was launched in the EU the 2011/62/EU Directive which aims to prevent the introduction of counterfeit medicines in the legal supply chain. In Europe exists many initiatives and organizations such as the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), Medicrime, Working Group of Enforcement Officers (WGEO), Pharmaceutical Security Institute (PSI), among others, whose main objective is to combat counterfeiting. They are organizations and initiatives with a high level of importance due to their work. Beyond these actions, Drug Regulatory Authority (DRA) have the Single Points of Contact (SPOCs) that enable information exchange and international collaboration so that everyone has access to the same information and cases detected. In Portugal, INFARMED I.P is the National Authority of Medicines and Health Products, and this authority has a duty to supervision and controls the stakeholders in the product cycle. In Infarmed, a department called 3C Cell is working daily to combat counterfeit medicines nationally. Some points are essential in combating counterfeiting medicines such as the implementation of the new Directive nationally and the continuation of cooperation between countries.
Descrição
Orientação : João Martins
Palavras-chave
FARMACOLOGIA, CONTRAFAÇÃO, MEDICAMENTOS, MESTRADO INTEGRADO EM CIÊNCIAS FARMACÊUTICAS, DRUGS, COUNTERFEIT, PHARMACOLOGY, CIÊNCIAS FARMACÊUTICAS, PHARMACEUTICAL SCIENCES